Design of the randomized, Phase III, QUAZAR AML Maintenance trial of CC-486 (oral azacitidine) maintenance therapy in acute myeloid leukemia

Gail J. Roboz*, Pau Montesinos, Dominik Selleslag, Andrew Wei, Jun Ho Jang, Jose Falantes, Maria T. Voso, Hamid Sayar, Kimmo Porkka, Paula Marlton, António Almeida, Sanjay Mohan, Farhad Ravandi, Guillermo Garcia-Manero, Barry Skikne, Hagop Kantarjian

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

28 Citations (Scopus)

Abstract

Older patients with acute myeloid leukemia (AML) have worse rates of complete remission and shorter overall survival than younger patients. The epigenetic modifier CC-486 is an oral formulation of azacitidine with promising clinical activity in patients with AML in Phase I studies. The Phase III, randomized, double-blind, placebo-controlled QUAZAR AML Maintenance trial (CC-486-AML-001) examines CC-486 maintenance therapy (300 mg/day for 14 days of 28-day treatment cycles) for patients aged ≥55 years with AML in first complete remission. The primary end point is overall survival. Secondary end points include relapse-free survival, safety, health-related quality of life and healthcare resource utilization. This trial will investigate whether CC-486 maintenance can prolong remission and improve survival for older patients with AML.
Original languageEnglish
Pages (from-to)293-302
Number of pages10
JournalFuture Oncology
Volume12
Issue number3
DOIs
Publication statusPublished - Feb 2016
Externally publishedYes

Keywords

  • Acute myeloid leukemia
  • CC-486
  • De novo
  • Elderly
  • Maintenance therapy
  • Oral azacitidine
  • Phase III
  • Secondary

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